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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05578976
Registration number
NCT05578976
Ethics application status
Date submitted
12/10/2022
Date registered
13/10/2022
Titles & IDs
Public title
A Study to Evaluate Change in Disease Activity of Subcutaneous (SC) Epcoritamab Combined With Intravenous and Oral Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
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Scientific title
A Phase 3, Randomized, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination With R-CHOP Compared to R-CHOP in Subjects With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)
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Secondary ID [1]
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2023-505277-32
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Secondary ID [2]
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M20-621
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Universal Trial Number (UTN)
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Trial acronym
EPCORE DLBCL-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Rituximab
Treatment: Drugs - Vincristine
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Prednisone
Experimental: Epcoritamab and R-CHOP - Participants will receive subcutaneous epcoritamab combined with intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by epcoritamab in 21-day cycles.
Experimental: R-CHOP and Rituximab - Participants will receive intravenous rituximab, cyclophosphamide, doxorubixin hydrochloride, vincristine and oral prednisone (R-CHOP) followed by intravenous rituximab in 21-day cycles.
Treatment: Drugs: Epcoritamab
Subcutaneous Injection (SC)
Treatment: Drugs: Cyclophosphamide
Intravenous (IV) Injection
Treatment: Drugs: Rituximab
IV Infusion
Treatment: Drugs: Vincristine
IV Infusion
Treatment: Drugs: Doxorubicin
IV Infusion
Treatment: Drugs: Prednisone
Oral; Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants with Progression-Free Survival (PFS) with an International Prognostic Index (IPI) of 3-5
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Assessment method [1]
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PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC), or death due to any cause whichever comes first.
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Timepoint [1]
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Up to Approximately 46 Months
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Secondary outcome [1]
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Number of Participants with PFS
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Assessment method [1]
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PFS is defined as the duration from randomization to the date of disease progression as determined by Lugano 2014 criteria as assessed by IRC, or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to Approximately 46 Months
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Secondary outcome [2]
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Number of Participants with Event-free survival (EFS)
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Assessment method [2]
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EFS is defined as the duration from randomization to the date of disease progression determined by Lugano criteria as assessed by IRC, IRC-assessed PR or SD followed by non protocol-specified NALT, a positive biopsy on or after end-of-treatment (EOT), regardless of whether NAL initiated, or death from any cause.
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Timepoint [2]
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Up to Approximately 46 Months
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Secondary outcome [3]
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Percentage of Participants with Complete Remission (CR)
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Assessment method [3]
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CR on or after EOT, determined by Lugano 2014 criteria as assessed by IRC.
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Timepoint [3]
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On or After to Approximately 28 Weeks
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Secondary outcome [4]
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Overall survival (OS)
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Assessment method [4]
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OS is defined as time from randomization until death due to any causes.
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Timepoint [4]
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Up to Approximately 76 Months
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Secondary outcome [5]
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Percentage of Participants with Minimal Residual Disease (MRD) Negativity
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Assessment method [5]
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The MRD negativity rate is defined as the percentage of participants who achieve MRD negativity prior to the initiation of any non-protocol-specified new anti-lymphoma therapy.
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Timepoint [5]
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Up to Approximately 46 Months
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Eligibility
Key inclusion criteria
* Planned to receive treatment with 6 cycles of standard rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) per investigator determination.
* Must have newly diagnosed, histologically confirmed CD20+ diffuse large b-cell lymphoma [DLBCL] (de novo or histologically transformed from a diagnosis of follicular lymphoma) at most recent representative tumor biopsy based on the pathology report, with a World Health Organization (WHO) 2016 classification and including:
* DLBCL, Not Otherwise Specified (NOS).
* High grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement with DLBCL morphology.
* T-cell/histiocyte-rich large B-cell lymphoma.
* Epstein Barr virus-positive DLBCL, NOS.
* Follicular lymphoma Grade 3b.
Note: The local pathology report must be available at Screening to support CD20+ DLBCL histology.
Composite/intermediate histology with any of the following components is not allowed: high grade B-cell lymphoma, NOS; Hodgkin's lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt; plasmablastic lymphoma or any CD20- lymphoma, such as anaplastic lymphoma kinase-positive large B-cell lymphoma, human herpesvirus type 8-positive DLBCL, or primary effusion lymphoma.
* Availability of archival or fresh or paraffin embedded tissue at Screening.
* Must have an IPI score of 2-5. The number of participants with IPI 2 will not exceed approximately 30% of the overall sample size.
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 prior to initiating R-CHOP treatment. Note that participant with an initial ECOG performance status >= 3 may be screened if pre-phase treatment is planned. Participant may be eligible if ECOG performance status were to improve to 0-2 during pre-phase treatment.
* Has at least one target lesion defined as:
* >= 1 measurable nodal lesion (long axis > 1.5 cm ) or >= 1 measurable extra-nodal lesion (long axis > 1 cm) on computed tomography (CT) scan or magnetic resonance imaging (MRI). AND
* Positron emission tomography (PET)-positive on PET-CT scan.
* Laboratory values meeting the criteria laid out in the protocol.
* Left ventricular ejection fraction must be >= 50% by multi-gated acquisition or transthoracic echocardiography at Screening.
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Minimum age
18
Years
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Maximum age
79
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* History of prior systemic anti-lymphoma therapy for diagnosed diffuse large b-cell lymphoma (DLBCL) including any definitive radiotherapy with curative intent] other than corticosteroids with or without vincristine during prephase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
* Clinically significant cardiovascular disease as per the protocol.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2029
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Actual
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Sample size
Target
900
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital /ID# 230072 - Liverpool
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Royal Adelaide Hospital /ID# 225683 - Adelaide
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Monash Medical Centre /ID# 225680 - Clayton
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Austin Health /ID# 225716 - Heidelberg
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The Alfred Hospital /ID# 225999 - Melbourne
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Hollywood Private Hospital /ID# 251837 - Nedlands
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Perth Blood Institute Ltd /ID# 225679 - Nedlands
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Royal Perth Hospital /ID# 226583 - Perth
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2170 - Liverpool
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5000 - Adelaide
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3168 - Clayton
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3084 - Heidelberg
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3004 - Melbourne
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6009 - Nedlands
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6000 - Perth
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0
Szeged
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Country [111]
0
0
Israel
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State/province [111]
0
0
H_efa
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Country [112]
0
0
Israel
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State/province [112]
0
0
HaMerkaz
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Country [113]
0
0
Israel
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State/province [113]
0
0
Tel-Aviv
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Country [114]
0
0
Israel
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State/province [114]
0
0
Yerushalayim
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Country [115]
0
0
Israel
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State/province [115]
0
0
Haifa
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Country [116]
0
0
Italy
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State/province [116]
0
0
Foggia
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Country [117]
0
0
Italy
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State/province [117]
0
0
L Aquila
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Country [118]
0
0
Italy
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State/province [118]
0
0
Milano
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Country [119]
0
0
Italy
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State/province [119]
0
0
Torino
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Country [120]
0
0
Italy
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State/province [120]
0
0
Alessandria
Query!
Country [121]
0
0
Italy
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State/province [121]
0
0
Aviano
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Country [122]
0
0
Italy
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State/province [122]
0
0
Brescia
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Country [123]
0
0
Italy
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State/province [123]
0
0
Novara
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Country [124]
0
0
Italy
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State/province [124]
0
0
Palermo
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Country [125]
0
0
Italy
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State/province [125]
0
0
Pisa
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Country [126]
0
0
Italy
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State/province [126]
0
0
Ravenna
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Country [127]
0
0
Japan
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State/province [127]
0
0
Aichi
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Country [128]
0
0
Japan
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State/province [128]
0
0
Chiba
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Country [129]
0
0
Japan
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State/province [129]
0
0
Ehime
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Country [130]
0
0
Japan
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State/province [130]
0
0
Fukuoka
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Country [131]
0
0
Japan
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State/province [131]
0
0
Fukushima
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Country [132]
0
0
Japan
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State/province [132]
0
0
Hokkaido
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Country [133]
0
0
Japan
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State/province [133]
0
0
Hyogo
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Country [134]
0
0
Japan
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State/province [134]
0
0
Ibaraki
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Country [135]
0
0
Japan
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State/province [135]
0
0
Ishikawa
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Country [136]
0
0
Japan
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State/province [136]
0
0
Kagoshima
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Country [137]
0
0
Japan
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State/province [137]
0
0
Kanagawa
Query!
Country [138]
0
0
Japan
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State/province [138]
0
0
Miyagi
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Country [139]
0
0
Japan
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State/province [139]
0
0
Osaka
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Country [140]
0
0
Japan
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State/province [140]
0
0
Tokyo
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Country [141]
0
0
Japan
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State/province [141]
0
0
Yamagata
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Country [142]
0
0
Japan
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State/province [142]
0
0
Okayama
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Country [143]
0
0
Korea, Republic of
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State/province [143]
0
0
Busan Gwang Yeogsi
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Country [144]
0
0
Korea, Republic of
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State/province [144]
0
0
Gyeonggido
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Country [145]
0
0
Korea, Republic of
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State/province [145]
0
0
Gyeongsangbugdo
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Country [146]
0
0
Korea, Republic of
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State/province [146]
0
0
Gyeongsangnamdo
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Country [147]
0
0
Korea, Republic of
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State/province [147]
0
0
Jeonrabugdo
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Country [148]
0
0
Korea, Republic of
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State/province [148]
0
0
Seoul Teugbyeolsi
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Country [149]
0
0
Korea, Republic of
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State/province [149]
0
0
Ulsan Gwang Yeogsi
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Country [150]
0
0
Netherlands
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State/province [150]
0
0
Flevoland
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Country [151]
0
0
Netherlands
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State/province [151]
0
0
Gelderland
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Country [152]
0
0
Netherlands
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State/province [152]
0
0
Noord-Brabant
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Country [153]
0
0
Netherlands
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State/province [153]
0
0
Noord-Holland
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Country [154]
0
0
Netherlands
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State/province [154]
0
0
Zuid-Holland
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Country [155]
0
0
Netherlands
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State/province [155]
0
0
Den Haag
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Country [156]
0
0
Netherlands
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State/province [156]
0
0
Deventer
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Country [157]
0
0
Netherlands
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State/province [157]
0
0
Groningen
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Country [158]
0
0
Netherlands
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State/province [158]
0
0
S Hertogenbosch
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Country [159]
0
0
Netherlands
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State/province [159]
0
0
Utrecht
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Country [160]
0
0
New Zealand
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State/province [160]
0
0
Auckland
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Country [161]
0
0
New Zealand
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State/province [161]
0
0
Canterbury
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Country [162]
0
0
Poland
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State/province [162]
0
0
Pomorskie
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Country [163]
0
0
Poland
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State/province [163]
0
0
Swietokrzyskie
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Country [164]
0
0
Poland
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State/province [164]
0
0
Warminsko-mazurskie
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Country [165]
0
0
Poland
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State/province [165]
0
0
Wielkopolskie
Query!
Country [166]
0
0
Portugal
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State/province [166]
0
0
Braga
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Country [167]
0
0
Portugal
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State/province [167]
0
0
Lisboa
Query!
Country [168]
0
0
Portugal
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State/province [168]
0
0
Porto
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Country [169]
0
0
Puerto Rico
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State/province [169]
0
0
Curitiba
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Country [170]
0
0
Puerto Rico
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State/province [170]
0
0
Manati
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Country [171]
0
0
Puerto Rico
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State/province [171]
0
0
Rio Piedras
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Country [172]
0
0
Slovakia
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State/province [172]
0
0
Bratislavsky Kraj
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Country [173]
0
0
Slovakia
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State/province [173]
0
0
Zilinsky Kraj
Query!
Country [174]
0
0
South Africa
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State/province [174]
0
0
Gauteng
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Country [175]
0
0
South Africa
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State/province [175]
0
0
Western Cape
Query!
Country [176]
0
0
Spain
Query!
State/province [176]
0
0
Barcelona
Query!
Country [177]
0
0
Spain
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State/province [177]
0
0
Cordoba
Query!
Country [178]
0
0
Spain
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State/province [178]
0
0
Murcia
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Country [179]
0
0
Spain
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State/province [179]
0
0
Navarra
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Country [180]
0
0
Spain
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State/province [180]
0
0
Madrid
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Country [181]
0
0
Spain
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State/province [181]
0
0
Valencia
Query!
Country [182]
0
0
Sweden
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State/province [182]
0
0
Skane Lan
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Country [183]
0
0
Sweden
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State/province [183]
0
0
Sodermanlands Lan
Query!
Country [184]
0
0
Sweden
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State/province [184]
0
0
Stockholms Lan
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Country [185]
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0
Sweden
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State/province [185]
0
0
Vastra Gotalands Lan
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Country [186]
0
0
Switzerland
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State/province [186]
0
0
Aargau
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Country [187]
0
0
Switzerland
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State/province [187]
0
0
Bern
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Country [188]
0
0
Switzerland
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State/province [188]
0
0
Zuerich
Query!
Country [189]
0
0
Taiwan
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State/province [189]
0
0
Kaohsiung
Query!
Country [190]
0
0
Taiwan
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State/province [190]
0
0
Keelung
Query!
Country [191]
0
0
Taiwan
Query!
State/province [191]
0
0
Taichung
Query!
Country [192]
0
0
Turkey
Query!
State/province [192]
0
0
Adana
Query!
Country [193]
0
0
Turkey
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State/province [193]
0
0
Kocaeli
Query!
Country [194]
0
0
Turkey
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State/province [194]
0
0
Malatya
Query!
Country [195]
0
0
Turkey
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State/province [195]
0
0
Samsun
Query!
Country [196]
0
0
Turkey
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State/province [196]
0
0
Yuregir
Query!
Country [197]
0
0
United Kingdom
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State/province [197]
0
0
London, City Of
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Country [198]
0
0
United Kingdom
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State/province [198]
0
0
Norfolk
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Country [199]
0
0
United Kingdom
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State/province [199]
0
0
Birmingham
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Country [200]
0
0
United Kingdom
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State/province [200]
0
0
Edinburgh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genmab
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Address
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Country
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Ethics approval
Ethics application status
Query!
Summary
Brief summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the change in disease activity of epcoritamab when combined with intravenous and oral rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP) or R-CHOP in adult participants globally with diffuse large b-cell lymphoma (DLBCL). Change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in groups called treatment arms. Participants will receive epcoritamab combined with R-CHOP, followed by epcoritamab or R-CHOP followed by rituximab will be explored. Approximately 900 adult participants with with newly diagnosed DLBCL will be enrolled in the study in approximately 315 sites in globally. In the Arm 1, participants will receive subcutaneous epcoritamab combined with intravenous and oral R-CHOP followed by subcutaneous epcoritamab in 21-day cycles. In the Arm 2, participants will receive intravenous and oral R-CHOP followed by intravenous rituximab in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
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Trial website
https://clinicaltrials.gov/study/NCT05578976
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
ABBVIE INC.
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Address
0
0
AbbVie
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05578976